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28.04.2010 – 13:59

Kowa Company, Ltd.

Pitavastatin Demonstrates Sustained Efficacy, Tolerability and LDL-C Target Attainment Over 52 Weeks

Wokingham, England, April 28, 2010 (ots/PRNewswire)

New long-term
phase III data published today in Atherosclerosis demonstrates that,
of patients with primary hypercholesterolaemia or combined
dyslipidaemia who received 4mg of pitavastatin, 74% and 73.5%
achieved NCEP* and EAS* low-density lipoprotein cholesterol (LDL-C)
targets at 52 weeks, respectively. At the end of this open-label
one-year extension study, reductions in LDL-C observed during
previous 12-week double-blind phase III studies were maintained
(104.3 mg/dL at week 52 compared with 105.6 mg/dL at the end of the
double-blind phase). Furthermore, high-density lipoprotein
cholesterol (HDL-C) levels rose continually over 52 weeks, with an
overall increase of 14.3% from initial baseline, while changes in
other efficacy parameters and ratios** were sustained during 52 weeks
treatment compared with the end of the double-blind studies. These
data demonstrate sustained efficacy of pitavastatin over the
Statins are considered the mainstay of dyslipidaemia treatment,
however many patients do not reach clinically optimal lipid
targets.(1-4) Previous studies have demonstrated that around half of
patients failed to reach LDL-C targets with the initially prescribed
dose of statin, and that of these, 86% had still not reached LDL-C
target after six months, despite dose adjustment and use of the
clinician's statin of choice.(5) Furthermore, 68.2% of patients in UK
general practice failed to reach optimal clinical levels of HDL-C
within a year of starting statin therapy;(6) these studies suggest
there is an unmet clinical need in the management of dyslipidaemia.
"This study confirms that pitavastatin is an effective and well
tolerated long-term treatment option for patients with
hypercholesterolaemia or combined dyslipidaemia," commented Dr. Leiv
Ose, MD PhD, Rikshospitalet, Oslo University Hospital, Norway, and
Study Investigator. "Many patients do not reach LDL-C targets on
their current treatment regimen, and this can be said for other
important lipid parameters including HDL-C. A statin which has the
potential to help healthcare professionals and patients alike achieve
lipid targets represents a welcome treatment option for the future."
Prior to this extension study, all patients had previously taken
part in one of two double-blind studies, and had received
pitavastatin (2mg or 4mg QD), atorvastatin (10mg or 20mg QD) or
simvastatin (20mg or 40mg QD) for 12 weeks. On completion of the two
studies, 1353 patients (42.5% males / 57.5% females; mean age 58.6
years) took part in this open-label extension study to assess the
long-term safety and tolerability of pitavastatin 4mg QD for up to 52
weeks; secondary objectives were to assess NCEP and EAS LDL-C target
attainment, other lipid and lipoprotein fractions.
    *National Cholesterol Education Program (NCEP) and European
     Atherosclerosis Society (EAS)
    **Efficacy parameters (Triglycerides, total cholesterol, non-HDL-C,
      Apo-A1 and Apo-B, high sensitivity C-reactive protein, oxidized LDL )
      and ratios (total cholesterol: HDL-C, non-HDL-C:HDL-C and Apo-B:Apo-A1)
Pitavastatin was well tolerated to 52 weeks; no serious
treatment-emergent adverse event (TEAE) was related to pitavastatin,
with the most commonly reported TEAEs being increased blood
creatinine kinase (5.8%), nasopharyngitis (5.4%) and myalgia (4.1%).
Additionally, there were no clinically significant abnormalities in
routine laboratory variables, urinalysis, vital signs or 12-lead ECG.
Pitavastatin also demonstrated a favourable safety and tolerability
profile throughout the extension study, exemplified by a low rate of
discontinuations due to adverse events.
"Data from this pivotal, phase III study demonstrates
pitavastatin's sustained and robust efficacy, safety and tolerability
profile" said Dr Neil Hounslow, Vice President of scientific affairs,
Kowa Research Europe. "With sustained efficacy, low rates of
discontinuations due to adverse events and continued increases in
HDL-C observed over 52 weeks, pitavastatin could provide clinicians
with a new option in the long-term treatment of patients with
hypercholesterolaemia or combined dyslipidaemia."
About pitavastatin
Pitavastatin (a statin) is a fully synthetic and highly potent
inhibitor of HMG-CoA reductase used for primary hypercholesterolaemia
and combined dyslipidaemia. Pitavastatin has a unique cyclopropyl
group on the base structure common to the statin class. Since its
2003 launch in Japan, pitavastatin has accumulated millions of
patient-years of exposure. Many of these patients have comorbidities
and are taking multiple medications. Kowa received FDA approval of
pitavastatin (LIVALO(R)) for the treatment of primary
hypercholesterolaemia and combined dyslipidaemia in August 2009 and
it will be launched in the U.S. in June 2010. Additionally, Kowa
filed in Europe in August 2008 using the decentralised authorisation
procedure and is due to receive a regulatory approval in mid 2010. In
much of Europe, pitavastatin will be marketed by Recordati.
Pitavastatin will be available in three dosage strengths (1 mg, 2 mg
and 4 mg).
About Kowa
Kowa Company, Ltd. (KCL) is a privately held multinational
company headquartered in Nagoya, Japan. Established in 1894, KCL is
actively engaged in various manufacturing and commercial activities
in the fields of pharmaceutical, life science, information
technology, textiles, machinery and various consumer products. KCL's
pharmaceutical division was founded in 1946, and is focused on
cardiovascular therapeutics, with sales of the company's flagship
product, LIVALO, totaling $440 million (14% market share) in Japan
during the last fiscal year and expected to exceed $600 million in
the near future.
Kowa Pharmaceuticals America, Inc. (KPA) is a specialty
pharmaceutical company focused primarily in the area of
cardiometabolic therapeutics. The company, started in 2001 as
ProEthic Pharmaceuticals, Inc., was acquired by KCL in September of
2008. A privately held company, KPA focuses its efforts on the
acquisition, development, licensing and marketing of pharmaceutical
products. Its lead product, LIPOFEN(R) (fenofibrate capsules), is
indicated as adjunctive therapy to diet to reduce elevated TG and to
increase HDL-C in adult patients with primary hypercholesterolemia or
mixed dyslipidaemia.
Kowa Research Europe, Ltd. (KRE), established in 1999 in the
United Kingdom, is responsible for European clinical trials for
Kowa's strategic global pharmaceutical development.
About Recordati
Recordati, established in 1926, is a European pharmaceutical
group,  listed on the Italian Stock Exchange (Reuters RECI.MI,
Bloomberg REC IM,  ISIN IT 0003828271),with a total staff of over
2,950, dedicated to the  research, development, manufacturing and
marketing of pharmaceuticals. It has headquarters in Milan, Italy,
operations in the main European countries, and a growing presence in
the new markets of Central and Eastern Europe. A European field force
of over 1,450 medical representatives promotes a wide range of
innovative pharmaceuticals, both proprietary and under license, in a
number of therapeutic areas including a specialized business
dedicated to treatments for rare diseases. Recordati's current and
growing coverage of the European pharmaceutical market makes it a
partner of choice for new product licenses from companies which do
not have European marketing organizations.
Recordati is committed to the research and development of new
drug entities within the cardiovascular and urogenital therapeutic
areas and of treatments for rare diseases. Consolidated revenue for
2008 was EUR689.6 million, operating income was EUR144.7 million and
net income was EUR100.4 million.
For more information about Recordati please visit
1. Phatak H et al Atherosclerosis 2009;202:225-33
2. Ferrières J et al Arch Cardiovasc Dis 2008;101:557-63
3. García Ruiz FJ et al Pharmacoeconomics 2004;22 Suppl 3:1-12
4. Hermans MP et al Acta Cardiol 2009;64:177-85
5. Foley KA, Simpson RJ Jr, Crouse JR III, et al., Effectiveness
of statin titration on low-density lipoprotein cholesterol goal
attainment in patients at high risk of atherogenic events Am J
Cardiol. 2003;92:79-81
6. Phatak H, Wentworth C, Sazonov V, et al., Prevalence and
predictors of lipid abnormalities in patients treated with statins in
the UK general practice Atherosclerosis 2009;202:225-33


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